High MyopiaNCT05095194
Influence of Capsular Tension Ring on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT
A study testing Cataract surgery with IOL implantation and with/without capsular tension ring implatation in people with High Myopia and Capsular Tension Ring, run by Wenzhou Medical University at 1 site in China.
Trial summary
The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation.Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- High Myopia, Capsular Tension Ring
- What is being tested?
- Cataract surgery with IOL implantation and with/without capsular tension ring implatation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients are diagnosed age related cataract with axial length over 26mm
- The patients' age over 50 years old
- The patients plan to receive cataract surgery in Eye hospital of Wenzhou Medical University
- The dialated pupils are over 6mm
- Patients are willing and able to complete the follow-ups.
Who cannot join
- Patients with other type of cataract
- Patients have complications in the surgery and after surgery
- Patients have other severe diseases of eyes
Trial locations and contacts
1 site in 1 country.
China1 site
Eye Hospital of Wenzhou Medical College
Hangzhou, Zhejiang
Pingjun Chang, 18868410303, 364669877@qq.com
Eye Hospital of Wenzhou Medical College Chang, 18868410303, 364669877@qq.com
About this study
The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation.Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity. Capsular tension rings were first introduced in the early 1990s for loosening and tightening the lens bag and maintaining the equatorial contour of the bag after cataract surgery.Today, capsular tension rings of many different designs are in use.The capsular tension rings can be used in eyes with fragile and split zonular fibers, as well as pseudoexfoliation, high myopia, Marfan syndrome, mature cataract and lens subluxation.The capsular tension ring reduces the incidence of decentration and tilt of the IOL by reducing capsular contraction. In addition, multi-focus IOL implantation combine with capsular tension ring result in smaller high-order aberrations in our eyes compared to cataract surgery with multi-focus IOL implantation alone.For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt ,decentration and displacement of IOL.Currently, there is no literature guidance to compare the results of cataract surgery combined with or without capsular tension ring implantation in patients with high myopia.Our hospital has Swept-source Optical Coherence Tomography ( SS-OCT,Casia2, TOMEY, Japan), which can accurately photograph the process of IOL capsule bending and the changes of lens position after cataract surgery. SS-OCT can be used to evaluate the influence of capsular tension ring on the dynamic changes of IOL-capsular complex in patients with high myopia after cataract surgery.
Read the detailed description
The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation.Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity. Capsular tension rings were first introduced in the early 1990s for loosening and tightening the lens bag and maintaining the equatorial contour of the bag after cataract surgery.Today, capsular tension rings of many different designs are in use.The capsular tension rings can be used in eyes with fragile and split zonular fibers, as well as pseudoexfoliation, high myopia, Marfan syndrome, mature cataract and lens subluxation.The capsular tension ring reduces the incidence of decentration and tilt of the IOL by reducing capsular contraction. In addition, multi-focus IOL implantation combine with capsular tension ring result in smaller high-order aberrations in our eyes compared to cataract surgery with multi-focus IOL implantation alone.For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt ,decentration and displacement of IOL.Currently, there is no literature guidance to compare the results of cataract surgery combined with or without capsular tension ring implantation in patients with high myopia.Our hospital has Swept-source Optical Coherence Tomography ( SS-OCT,Casia2, TOMEY, Japan), which can accurately photograph the process of IOL capsule bending and the changes of lens position after cataract surgery. SS-OCT can be used to evaluate the influence of capsular tension ring on the dynamic changes of IOL-capsular complex in patients with high myopia after cataract surgery.
- Conditions
- High Myopia, Capsular Tension Ring
- Being tested
- Cataract surgery with IOL implantation and with/without capsular tension ring implatation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with IOL implantation and with/without capsular tension ring implatationProcedure or surgery
Patients in this study will receive cataract surgery with IOL implantation and capsular tension ring implantation or cataract surgery with IOL implantation
| Study group | Role | What they receive |
|---|---|---|
| High myopia patients who had cataract surgery with IOL and capsular tension ring implantation | Experimental | The patients' axial length is over 26 mm and are diagnosed age related cataract The patients' age are over 50 Receives: Procedure: Cataract surgery with IOL implantation and with/without capsular tension ring implatation |
| High myopia patients who had cataract surgery with IOL implantation | Experimental | The patients' axial length is over 26 mm and are diagnosed age related cataract The patients' age are over 50 Receives: Procedure: Cataract surgery with IOL implantation and with/without capsular tension ring implatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The position of IOL
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
Measured: The 1st day after surgery
The position of IOL
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
Measured: The 1st week after surgery
The position of IOL
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
Measured: The 1st month after surgery
The position of IOL
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
Measured: The 3rd month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095194
- Sponsor's protocol ID
- 20210929CTR
- Status last verified
- Oct 2021
- First submitted
- 30 Sep 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Capsular Tension Ring on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT
- ClinicalTrials.gov ID
- NCT05095194
- Acronym / sponsor ID
- 20210929CTR
- Conditions
- High Myopia, Capsular Tension Ring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation.Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity. Capsular tension rings were first introduced in the early 1990s for loosening and tightening the lens bag and maintaining the equatorial contour of the bag after cataract surgery.Today, capsular tension rings of many different designs are in use.The capsular tension rings can be used in eyes with fragile and split zonular fibers, as well as pseudoexfoliation, high myopia, Marfan syndrome, mature cataract and lens subluxation.The capsular tension ring reduces the incidence of decentration and tilt of the IOL by reducing capsular contraction. In addition, multi-focus IOL implantation combine with capsular tension ring result in smaller high-order aberrations in our eyes compared to cataract surgery with multi-focus IOL implantation alone.For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt ,decentration and displacement of IOL.Currently, there is no literature guidance to compare the results of cataract surgery combined with or without capsular tension ring implantation in patients with high myopia.Our hospital has Swept-source Optical Coherence Tomography ( SS-OCT,Casia2, TOMEY, Japan), which can accurately photograph the process of IOL capsule bending and the changes of lens position after cataract surgery. SS-OCT can be used to evaluate the influence of capsular tension ring on the dynamic changes of IOL-capsular complex in patients with high myopia after cataract surgery.
Detailed description
The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation.Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity. Capsular tension rings were first introduced in the early 1990s for loosening and tightening the lens bag and maintaining the equatorial contour of the bag after cataract surgery.Today, capsular tension rings of many different designs are in use.The capsular tension rings can be used in eyes with fragile and split zonular fibers, as well as pseudoexfoliation, high myopia, Marfan syndrome, mature cataract and lens subluxation.The capsular tension ring reduces the incidence of decentration and tilt of the IOL by reducing capsular contraction. In addition, multi-focus IOL implantation combine with capsular tension ring result in smaller high-order aberrations in our eyes compared to cataract surgery with multi-focus IOL implantation alone.For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt ,decentration and displacement of IOL.Currently, there is no literature guidance to compare the results of cataract surgery combined with or without capsular tension ring implantation in patients with high myopia.Our hospital has Swept-source Optical Coherence Tomography ( SS-OCT,Casia2, TOMEY, Japan), which can accurately photograph the process of IOL capsule bending and the changes of lens position after cataract surgery. SS-OCT can be used to evaluate the influence of capsular tension ring on the dynamic changes of IOL-capsular complex in patients with high myopia after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High myopia patients who had cataract surgery with IOL and capsular tension ring implantation | Experimental | Procedure: Cataract surgery with IOL implantation and with/without capsular tension ring implatationThe patients' axial length is over 26 mm and are diagnosed age related cataract The patients' age are over 50 |
| High myopia patients who had cataract surgery with IOL implantation | Experimental | Procedure: Cataract surgery with IOL implantation and with/without capsular tension ring implatationThe patients' axial length is over 26 mm and are diagnosed age related cataract The patients' age are over 50 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patients are diagnosed age related cataract with axial length over 26mm
- The patients' age over 50 years old
- The patients plan to receive cataract surgery in Eye hospital of Wenzhou Medical University
- The dialated pupils are over 6mm
- Patients are willing and able to complete the follow-ups.
Key exclusion criteria (3 listed)
- Patients with other type of cataract
- Patients have complications in the surgery and after surgery
- Patients have other severe diseases of eyes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgery with IOL implantation and with/without capsular tension ring implatationPatients in this study will receive cataract surgery with IOL implantation and capsular tension ring implantation or cataract surgery with IOL implantation | Procedure or surgery | High myopia patients who had cataract surgery with IOL and capsular tension ring implantation, High myopia patients who had cataract surgery with IOL implantation |
Primary outcome
The position of IOL
Time frame: The 1st day after surgery
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
The position of IOL
Time frame: The 1st week after surgery
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
The position of IOL
Time frame: The 1st month after surgery
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
The position of IOL
Time frame: The 3rd month after surgery
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery with IOL implantation and with/without capsular tension ring implatation in people with High Myopia and Capsular Tension Ring, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pingjun Chang (18868410303, 364669877@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The position of IOL (time frame: The 1st day after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.